Job Description

:
The Clinical Research Nurse is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). Assists with the execution of study-related activities of a Phase I clinical research study. Research nurses should primarily be concerned with the protection and care of research subjects. The primary role is to function as a licensed registered nurse engaged in the practice of care/assessments of the healthy volunteers and/or patient. Position includes disseminating information regarding new information for documentation, performance improvement and data source upgrades.

• Review protocols and informed consent forms for scheduled studies, identify and communicate potential issues to the appropriate personnel.
• Participate in nursing study related activities as required by protocol compliance with Corporate, divisional, and departmental SOP's and external (CFR, ICH GCP) regulatory guidelines.
• Responsible for compliance with applicable Corporate and Divisional Policies and Procedures.
• Evaluate adverse events and manage safety reporting activities in a timely manner.
• Interact with the Principal Investigator and other study physicians, Recruiting/Screening, Data Systems, and other personnel in support of study-specific activities.
• Support quality and compliance improvement initiatives as appropriate.
• Participate in the recruitment and screening activities to ensure successful enrollment of volunteers into studies scheduled at the Phase 1 Unit.
• Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol.
• Review and assess data collected.
• Serve as a resource person or act as a consultant within area of clinical expertise (R/S).
• Disburses investigational drug and provides teaching regarding administration, as necessary.
• Develops accurate source materials and ensures compliance from site staff. Ensures all protocol procedures are completed per study requirements (Unit).
• Other tasks as assigned.

Skills:

• Communication skills.
• Listening and answering vol.
• Multitasking.
• Nursing skills.

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